Safety and Tolerability of Dabigatran Etexilate in Adolescents

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran

Criteria

Inclusion criteria:

1. males or females 12 to less than 18 years of age

2. objective diagnosis of primary VTE

3. completion of planned treatment course with LMWH or OAC for primary VTE

4. written informed consent by parent (legal guardian) and patient assent

Exclusion criteria:

1. weight less than 32 kg

2. conditions associated with increased risk of bleeding

3. severe renal dysfunction or requirement for dialysis

4. active infective endocarditis

5. hepatic disease

6. pregnant females or females not using medically accepted contraceptive method

7. anemia or thrombocytopenia

8. use of prohibited or restricted drug within previous week

9. received investigational drug within past 30 days

10. unreliable patients or patients who have any condition that would not allow safe participation in study